EMA Information Day on Risk Management Planning – Implementation of GVP V and RMP Template Rev 2 Guidance

REGISTER EARLY! This Information Day is aimed at providing MAHs and MAAs with practical advice on RMP drafting using the principles of risk assessment and management included in GVP V Rev 2.

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THE EU RISK MANAGEMENT SYSTEM: STAKEHOLDERS INTERACTION – AREAS OF FUTURE FOCUS

Session Chair(s)

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management)

European Medicines Agency, Netherlands

Sabine Straus, MD, PhD, MSc

PRAC Chair, Staff Member

Medicines Evaluation Board (MEB), Netherlands

Areas where RM guidance is still being developed will be introduced by EMA; PRAC view on further guidance will be complemented by an open panel discussion. A hot topic from the pharmacovigilance area will be highlighted by the PRAC.

Speaker(s)

Practical advice on content requirements for generic, biosimilar, and fixed dose combination medicinal products; Product life cycle

Nuria Semis-Costa, MSc

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

Expectations and Pratical Advice from the view of an Assessor

Nils Lilienthal, PhD, MSc

Federal Institute for Drugs and Medical Devices (BfArM), Germany

Pharmacovigilance assessor (Drug safety)

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